Switzerland, Liechtenstein and the AstraZeneca reference: your chance to comment

Readers of The SPC Blog will be familiar with the UK litigation between AstraZeneca AB and the Comptroller of Patents, Designs and Trade Marks since this blog posted a note on it back in October of last year.  This case has now resurfaced as a reference to the Court of Justice of the European Union with the new designation of Case C-617/12  AstraZeneca.

The UK's Intellectual Property Office reminds us that the referring court has asked the following questions:

"1. Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the 'first authorisation to place the product on the market' for the purposes of Article 13(1) of Regulation 469/2009/EC?

2. Does it make a difference to the answer to the first question if:

(a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or

(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?

3. If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?".

If you would like to comment on this case and, by doing so, encourage the UK government to take a position on whether to make observations to the CJEU, please email policy@ipo.gsi.gov.uk by 28 February 2013.  We know there's not much time, but ...

Isoxadifen and SPCs for safeners: UK invites comments

Following on from The SPC Blog's earlier posts here and here, the UK Intellectual Property Office has now issued a circular inviting interested parties to comment on the Court of Justice of the European Union reference in Case C-11/13 Bayer CropScience so that the UK government can decide what, if any, position it wishes to take with regard to the question referred. To jog readers' memories, the IPO explains:

The appellant is seeking a supplementary protection certificate for ‘Isoxadifen and the salts and esters thereof’. Isoxadifen is a ‘safener’, that is, a substance added to a product to prevent the harmful action of an herbicide in plants.

The referring Court asks whether such a safener falls within the meaning of the terms ‘product’ in Article 3(1) and Article 1(8), and ‘active substance’ in Article 1(3) of the Regulation.

While the precise official English version of the reference from the German Bundespatentgericht does not appear to be available, the gist of the question is clear.

If you would like to comment on this case please email policy@ipo.gsi.gov.uk by 25 February 2013.